Male sexual impotence treatment apparatus

ABSTRACT

A male sexual impotence treatment apparatus comprises an adjustable restriction device ( 234 ) implanted in an impotent patient and engaging the corpora cavernosa or crura or the prolongation thereof ( 244 ). An implanted adjustment device is adapted to adjust the restriction device to temporarily contract the corpora cavernosa, in order to restrict the blood flow leaving the penis when the patient desires to achieve erection. An implanted powered hydraulic operation device ( 246 ) operates the adjustment device.

[0001] The present invention relates to a male sexual impotencetreatment apparatus comprising an adjustable restriction deviceimplantable in a male impotent patient for engaging the corporacavernosa or crura or the prolongations thereof of the patient's peniletissue. An implantable adjustment device is provided for adjusting therestriction device to temporarily contract the corpora cavernosa orcrura or the prolongations thereof to restrict the blood flow leavingthe penis, and an implantable operation device is provided for operatingthe adjustment device.

[0002] Male sexual impotence is a widespread problem. Many differentsolutions to this problem have been tried. A main solution currentlypractised and disclosed in for instance U.S. Pat. Nos. 5,437,605 and4,841,461 is to implant a hydraulic inflatable/contractable siliconprosthesis in the cavities of the corpora cavernosa of the patient'spenis. In fluid connection with this prosthesis is a reservoir implantedin the scrotum. By manual pumping action the prosthesis is filled withfluid from the reservoir to effect errect penile condition or is emptiedof fluid, which returns to the reservoir, to effect flaccid penilecondition. However, there are several more or less severe disadvantagesof this main solution. Above all, the penis is more or less damaged bythe operation and it is practically impossible to reverse the operation.Another disadvantage is that rather strong forces act against thisimplanted prosthesis resulting in a significant risk of the prosthesisbeing broken.

[0003] Another solution to achieve erection is to restrict the bloodflow leaving the penis. For example, U.S. Pat. No. 4,829,990 disclosestwo hydraulically operated inflatable cuffs wrapped around therespective crura. A disadvantage of such a solution is that it involvescomplicated surgery. Another example on this solution is U.S. Pat. No.4,828,544, which discloses an artificial fistula system surgicallyimplanted and providing a primary fistula between the femoral artery andthe femoral vein and a secondary fistula for leading blood from the theprimary fistula to the penis. An inflatable balloon engages the primaryfistula between the secondary fistula and the vein. The balloon is influid connection with a manually compressible reservoir implanted in thescrotum. Again, implantation of this artifical fistula system requiresdelicate surgery.

[0004] Yet another solution is to inject a substance in the penile veinsystem to achieve erection. However, injections are painful andcomplicated for the patient.

[0005] The object of the present invention is to provide a simple malesexual impotence treatment apparatus, which requires relativelyuncomplicated surgery.

[0006] This objekt is obtained by an apparatus of the kind describedinitially characterised in that the operation device comprises a poweredoperation device.

[0007] With the expression “the prolongations thereof” should beunderstood the penile tissue extending from the crura inside the humanbody and following the pathway of the blood flow leaving the penis, i.e.where the penile exit veins extend.

[0008] Generally, the restriction device is adapted to contract thecorpora cavernosa or crura or the prolongations thereof as a singleunit, which requires relatively simple surgery. Alternatively, however,the restriction device may comprise two restriction members adapted tocontract the respective corpora cavernosa or crura or the prolongationsthereof.

[0009] The restriction device may control the contraction of the corporacavernosa or crura or the prolongations thereof, preferably to changesteplessly. Suitably, the adjustment device adjusts the restrictiondevice such that the restriction device provides a predeterminedcontraction of the corpora cavernosa or crura or the prolongationsthereof that is satisfactory for the patient. A satisfactory contractionis achieved when the differential pressure between the arterial andvenous penile blood pressures has increased enough to cause erection ofthe patient's penis while blood still is flowing through the penis.

[0010] The adjustment device preferably adjusts the restriction devicein a non-invasive manner.

[0011] The adjustment device may adjust the restriction device in anon-magnetic manner, i.e. magnetic forces may not be involved whenadjusting the restriction device. Also, the adjustment device may adjustthe restriction device in a non-thermal manner, i.e. thermal energy maynot be involved when adjusting the restriction device.

[0012] The expression “powered” should be understood as energised witheverything without manual force, preferably electric energy. In otherwords, the adjustment device is operated in a non-manual manner. Theexpression “non-manual manner” should be understood to mean that theadjustment device is not operated by manually touching subcutaneouslyimplanted components of the apparatus or not manipulated by touching theskin of the patient. Thus, as opposed to prior practice when treatingmale sexual impotence, the adjustment device of the invention is notoperated by manual forces, such as by manually compressing a fluidcontaining balloon implanted in the scrotum or in the region of labiamajora. Of course, manual manipulation of a subcutaneous start button orthe like for activating the powered operation device is permitted withinthe scope of the present invention.

[0013] Alternatively, or in combination with a powered operation device,the servo means may be used, which enables manual manipulation withoutneed for strong manipulation forces. The servo means may comprisehydraulic means, electric control means, magnetic means, or mechanicalmeans, which may be activated by manual manipulating means. Using aservo system will save the use of force when adjusting the adjustmentdevice, which may be of importance in many applications.

[0014] The term “servo means” encompasses the normal definition of aservo mechanism, i.e. an automatic device that controls large amounts ofpower by means of very small amounts of power, but may alternatively oradditionally encompass the definition of a mechanism that transfers aweak force acting on a moving element having a long stroke into a strongforce acting on another moving element having a short stroke. The servomeans may comprise a motor, preferably an electric motor, which may bereversible.

[0015] In accordance with a main embodiment of the invention, theapparatus comprises a reservoir, preferably containing a predeterminedamount of hydraulic fluid, also implantable in the patient, wherein theoperation device, suitably electrically powered, operates the adjustmentdevice by using the hydraulic fluid of the reservoir.

[0016] The adjustment device may comprise an expandable cavity in therestriction device, wherein the corpus cavernosum or crura or theprolongation thereof is sqeezed upon expansion of the cavity andreleased upon contraction of the cavity. In this embodiment theoperation device is adapted to distribute hydraulic fluid from thereservoir to expand the cavity, and from the cavity to the reservoir tocontract the cavity.

[0017] A fluid distribution tube may readily be connected between thereservoir and the cavity in a manner so that the tube does not interferewith other implanted components of the apparatus.

[0018] Preferably, the reservoir defines a chamber for the predeterminedamount of fluid and the operation device changes the volume of thechamber. The operation device suitably comprises first and second wallportions of the reservoir and is adapted to provide relativedisplacement between the first and second wall portions of thereservoir, in order to change the volume of the chamber.

[0019] The operation device may be adapted to provide said relativedisplacement in response to the pressure in the reservoir. Suitably, theoperation device comprises a pressure controlled hydraulic operationdevice. For safety, an alarm may be provided for generating an alarmsignal in response to the lapse of a predetermined time period duringwhich the pressure controlling the hydraulic operation device exceeds apredetermined high value.

[0020] Suitably, the operation device is adapted to distribute fluidfrom the reservoir to the cavity of the restriction member in responseto a predetermined first displacement of the first wall portion of thereservoir relative to the second wall portion of the reservoir and maydistribute fluid from the cavity to the reservoir in response to apredetermined second displacement of the first wall portion relative tothe second wall portion.

[0021] The first and second wall portions of the reservoir may bedisplaceable relative to each other by a magnetic, hydraulic, orelectric power means, such as an electric motor. In this embodiment nopump is used, only the volume of the reservoir is varied. This is ofgreat advantage compared to the solution described below when theoperation device comprises a pump used to pump fluid between thereservoir and the adjustment device because there is no need for anon-return valve and it is still possible to have fluid going both toand from the reservoir. Thus, the significant risk of malfunction whenusing such a non-return valve implanted in the patient is eliminated.

[0022] The operation device may comprise hydraulic means and a fluidconduit extending between the hydraulic means and the adjustment device.The hydraulic means and conduit are devoid of any non-return valve. Thereservoir may form part of the conduit and a fluid chamber with avariable volume. The operation device may distribute fluid from thefluid chamber to the adjustment device by reduction of the volume of thechamber and withdraw fluid from the adjustment device by expansion ofthe volume of the chamber. The operation device preferably comprises amotor for moving a movable wall of the reservoir for changing the volumeof the chamber. Any kind of motor could be used for the differentoperations as well as wireless remote solutions for controlling theoperations.

[0023] The restriction device preferably is operable to perform areversible function and accordingly there is a reversing deviceimplantable in the patient for reversing the function performed by therestriction device. Such a reversing function preferably involvesenlarging and restricting the blood flow passageway by the restrictiondevice, suitably in a stepless manner. In this connection, the controldevice suitably controls the reversing device, which may include aswitch, to reverse the function performed by the restriction device. Thereversing device may comprise hydraulic means including a valve forshifting the flow direction of a fluid in the hydraulic means.Alternatively, the reversing device may comprise a mechanical reversingdevice, such as a switch or a gearbox.

[0024] Where the reversing device comprises a switch the control devicesuitably controls the operation of the switch by shifting polarity ofreleased energy supplied to the switch. The switch may comprise anelectric switch and the source of energy may supply electric energy forthe operation of the switch. The switch mentioned above may comprise anelectronic switch or, where applicable, a mechanical switch.

[0025] Where the operation device comprises a motor, the reversingdevice is adapted to reverse the motor.

[0026] In accordance with another particular embodiment of theinvention, the operation device comprises a pump for pumping fluidbetween the reservoir and the adjustment device. A mechanical solutionis proposed in which it is possible to pump fluid from the reservoir tothe adjustment device and vice versa just by pushing an activationmember in one direction. The pump preferably comprises a firstactivation member for activating the pump to pump fluid from thereservoir to the adjustment device, and a second activation member foractivating the pump to pump fluid from the adjustment device to thereservoir. At least one of the first and second activation members maybe operable by manual manipulation, preferably to permit manual pushing,pulling or rotation thereof in one direction, or by a device poweredmagnetically, hydraulically, or electrically (e.g. by an electricmotor), or be operable by a combination of these methods. Suitably, atleast one of the activation members may be adapted to operate whensubjected to an external pressure exceeding a predtermined magnitude.

[0027] Another alternative is a pump pumping in only one direction andan adjustable valve to change the direction of fluid to either increaseor decrease the amount of fluid in the reservoir. This valve may bemanipulated either manually, mechanically, magnetically, orhydraulically.

[0028] The main embodiment of the invention described above includingthe reservoir may alternatively be equipped with a servo meanscomprising a reverse servo. The term “reverse servo” is to be understoodas a mechanism that transfers a strong force acting on a moving elementhaving a short stroke into a weak force acting on another moving elementhaving a long stroke; i.e. the reverse function of the above-definedalternative mechanism of a normal servo mechanism. A first closedhydraulic system that controls another closed hydraulic system in whichhydraulic means of the adjustment device is incorporated may be used.Minor changes in the amount of fluid in a smaller reservoir of the firstsystem could then be transferred by the reverse servo into major changesin the amount of fluid in a larger reservoir in the second system. Inconsequence, the change of volume in the larger reservoir of the secondsystem affects the hydraulic means of the adjustment device. Forexample, a short stroke that decreases the volume of the smallerreservoir will cause the larger reservoir to supply the adjustmentdevice with a large amount of hydraulic fluid, which in turn results ina long mechanical adjustment stroke on the restriction device.

[0029] The great advantage of using such a reverse servo is that thelarger volume system could be placed inside the abdomen orretroperitoneum where there is more space and still it would be possibleto use manual manipulation means of the smaller system subcutaneously.The smaller reservoir could be controlled directly or indirectly by afluid supply means. The fluid supply means may include another smallreservoir, which may be placed subcutaneously and may be activated bymanual manipulation means. Both the normal servo means and the specificreverse servo may be used in connection with all of the variouscomponents and solutions described in the present specification.

[0030] Thus, the reverse servo may be adapted to provide relativedisplacement between the first and second wall portions of thereservoir, suitably in response to the pressure in the reservoir, inorder to change the volume of the chamber of the reservoir.

[0031] Generally, the servo means, including the reverse servo,comprises a pressure controlled servo means. The alarm mentioned abovemay alternatively be adapted to generate an alarm signal in response tothe lapse of a predetermined time period during which the pressurecontrolling the servo means exceeds a predetermined high value.

[0032] The reverse servo may comprise magnetic means, electric means ormanual manipulation means or a combination thereof. Preferably, however,the reverse servo comprises hydraulic means.

[0033] In accordance with a particular embodiment of the invention, thereverse servo further comprises a servo reservoir defining a chambercontaining servo fluid, and the operation device comprise first andsecond wall portions of the servo reservoir, which are displaceablerelative to each other to change the volume of the chamber of the servoreservoir. The first and second wall portions of the servo reservoir maybe displaceable relative to each other by magnetic means, hydraulicmeans, or electric control means.

[0034] Where the reverse servo comprises hydraulic means it may furthercomprise a fluid supply reservoir connected to the servo reservoir in aclosed system and containing a further predetermined amount of fluid.The fluid supply reservoir defines a chamber for the furtherpredetermined amount of fluid and the operation device is adapted tochange the volume of the chamber and thereby control the amount of fluidin the servo reservoir. The fluid supply reservoir comprises first andsecond wall portions, which are displaceable relative to each other tochange the volume of the chamber of the fluid supply reservoir.Suitably, the fluid supply reservoir increases the amount of fluid inthe servo reservoir in response to a predetermined first displacement ofthe first wall portion of the fluid supply reservoir relative to thesecond wall portion of the fluid supply reservoir and decreases theamount of fluid in the servo reservoir in response to a predeterminedsecond displacement of the first wall portion of the fluid supplyreservoir relative to the second wall portion of the fluid supplyreservoir.

[0035] In accordance with an embodiment of the invention, the adjustmentdevice comprises a hydraulic adjustment device, and an implantablereservoir containing a predetermined amount of hydraulic fluid and aconduit providing fluid connection between the reservoir and thehydraulic adjustment device are provided. The operation device isadapted to operate the hydraulic adjustment device by distributinghydraulic fluid through the conduit between the reservoir and thehydraulic adjustment device, wherein the conduit and hydraulicadjustment device are devoid of any non-return valve to permit free flowof hydraulic fluid in both directions in the conduit. Preferably, thereservoir forms a fluid chamber with a variable volume, and theoperation device is adapted to distribute fluid from the chamber to theadjustment device by reduction of the volume of the chamber and towithdraw fluid from the adjustment device by expansion of the volume ofthe chamber. The operation device may comprise a motor or a pump.Alternatively, the operation device may comprise a movable wall of thereservoir for changing the volume of the chamber. For example, theoperation device may be adapted to change the volume of the chamber bymoving the movable wall in response to the pressure in the chamber.

[0036] In the above embodiments including a reservoir for hydraulicfluid an injection port may be provided for subcutaneous implantation inthe patient to be in fluid communication with the chamber of thereservoir. The injection port may be integrated in the reservoir. Suchan injection port may be provided for enabling, normally single,once-and-for-all, calibration of the amount of fluid in the hydraulicsystem used.

[0037] In the various embodiments hereinafter described the restrictiondevice generally forms an at least substantially closed loop. However,the restriction device may take a variety of different shapes, such asthe shape of a square, rectangle or ellipse. The substantially closedloop could for example be totally flat, i.e. thin as seen in the radialdirection. The shape of restriction device may also be changed duringuse, by rotation or movements of the restriction device in anydirection. A physical lumen, such as the corpora cavernosa or crura,often is easier to contract by moving two opposite sidewalls of thelumen against each other. Thus, the restriction device may be designedto perform such a contracting effect of the opposite walls of thecorpora cavernosa or crura or the prolongations thereof, oralternatively the opposite walls of each one of the corpora cavernosa orcrura or the prolongations thereof. Either mechanical or hydraulicsolutions may be employed to operate the restriction device.Alternatively, the restriction device may comprise an adjustable cuff, aclamp or a roller for bending or rotating the corpora cavernosa or cruraor the prolongations thereof to contract them. The bending or rotatingmembers may take any shape and be either hydraulic or non-inflatable.

[0038] Preferably the restriction device comprises an elongatedrestriction member and forming means for forming the restriction memberinto at least a substantially closed loop around the corpora cavernosaor crura or the prolongations thereof, wherein the loop defines arestriction opening, whereby the adjustment device adjusts therestriction member in the loop to restrict the blood flow leaving thepenis.

[0039] Advantageously, the forming means may form the restriction memberinto a loop having a predetermined size. Alternatively, the formingmeans may form the restriction member into a loop selected from severalpredetermined sizes.

[0040] The adjustment device may change the size of the restrictionopening such that the outer circumferential confinement surface of therestriction member either is changed or is unchanged.

[0041] The elongated restriction member may be flexible, for exampletake the shape of a belt or cord, and the adjustment device may pull afirst portion of the flexible restriction member from a second portionof the flexible restriction member opposite the first portion in theloop to squeeze the corpora cavernosa or crura or the prolongationsthereof between the opposite lengths of the elongated flexiblerestriction member to restrict the blood flow leaving the penis. Therestriction member may be non-inflatable, and the adjustment device maymechanically adjust the restriction member in the loop.

[0042] Preferably the adjustment device is operable to adjust therestriction device to steplessly change the contraction of the corporacavernosa or crura or the prolongations thereof.

[0043] The adjustment device may mechanically or hydraulically adjustthe restriction device. In the embodiments described the adjustmentdevice may either mechanically or hydraulically adjust the restrictiondevice, where applicable. It should be noted that the operation devicemight mechanically or hydraulically operate the adjustment deviceirrespectively of whether the adjustment device is adapted to adjust therestriction device mechanically or hydraulically.

[0044] In accordance with an embodiment of the invention, therestriction device comprises at least two elements on opposite ordifferent sides of the corpus cavernosum or crura or the prolongationthereof, and the adjustment device decreases the distance between theelements to squeeze the corpus cavernosum or crura or the prolongationthereof between the elements, thereby restricting the blood flowpassageway. It is also possible to use only one element and squeeze thecorpus cavernosum or crura or the prolongation thereof against humanbone or tissue. The elements above may as well as all the restrictionmembers mentioned in this application be everything from rigid to soft.

[0045] In accordance with an alternative, the restriction device bendsor rotates a portion of the corpus cavernosum or crura or theprolongation thereof to restrict the blood flow passageway in the same.For example, the restriction device may comprise at least two bendingmembers, such as cylindrical or hour-glass shaped rollers, positioned onopposite or different sides of the corpus cavernosum or crura or theprolongation thereof and displaced relative to each other along thecorpus cavernosum or crura or the prolongation thereof, and theadjustment device may move the bending members against the corpuscavernosum or crura or the prolongation thereof to bend the latter torestrict the blood flow passageway. The restriction device may alsorotate a portion of the corpus cavernosum or crura or the prolongationthereof. The bending or rotating members may take any shape and beeither hydraulic or non-inflatable.

[0046] Alternatively, the two bending members one placed more distalthan the other may be rotated in opposite directions relative to eachother. With interconnecting means for example flexible bands between thebending members a restriction will occur between the bending memberswhen they are rotated.

[0047] Preferably the adjustment device is operable to adjust therestriction device to steplessly change the restriction of the bloodflow passageway in the corpus cavernosum or crura or the prolongationthereof.

[0048] All embodiments according to the invention may be controlled by awireless remote control.

[0049] In accordance with an advantageous embodiment of the invention,there is provided a wireless remote control for non-invasivelycontrolling the operation device. The remote control may convenientlycomprise an external hand-held remote control unit, which is manuallyoperable by the patient to control the restriction device to squeeze andrelease the corpus cavernosum or crura or the prolongation thereof. Withthe wireless remote control the apparatus of the invention isconveniently controlled by the patient when he so desires, which is ofgreat advantage compared to the prior art procedures. With the remotecontrol the apparatus of the invention is conveniently controlled toadjust the implanted restriction device to release the blood flowpassageway when the patient wants to relieve himself or herself.

[0050] The remote control may advantageously be capable of obtaininginformation related to important parameters, such as the condition ofthe blood flow passageway or the pressure against the restrictiondevice, and of commanding the operation device to operate the adjustmentdevice to adjust the restriction device in response to obtainedinformation. With the remote control the apparatus of the invention isconveniently controlled to adjust the implanted restriction device toopen and close the blood flow passageway. The adjustment device maycontrol the restriction device to steplessly change the restriction ofthe passageway.

[0051] Preferably, the wireless remote control comprises a separatesignal transmitter or receiver and a signal receiver or transmitterimplanted in the patient. For example, the signal transmitter and signalreceiver may transmit and receive a signal in the form of digitalpulses, which may comprise a magnetic or electric field. Alternatively,which is preferred, the signal transmitter and signal receiver maytransmit and receive an electromagnetic wave signal, a sound wave signalor a carrier wave signal for a remote control signal. The receiver maycomprise an implanted control unit for controlling the adjustment devicein response to a control signal from the signal transmitter. Any knownor conventional signal transmitting or signal receiving means that issuitable for use with a human or mammal patient may be provided as thesignal transmitter or signal receiver.

[0052] The apparatus of the invention may further comprise an implantedenergiser unit for providing energy to energy consuming implantedcomponents of the apparatus, such as electronic circuits and/or a motorfor operating the adjustment device. Where a motor is provided thecontrol unit is adapted to power the motor with energy provided by theenergiser unit in response to a control signal received from the signaltransmitter. The motor may be any type of motor, such as a pneumatic,hydraulic or electric motor and the energiser unit may power the motorwith pressurized gas or liquid, or electric energy, depending on thetype of motor. Where the motor is an electric motor, it may powerpneumatic or hydraulic equipment.

[0053] The remote control advantageously comprises wireless energytransfer device for transferring energy from outside the patient's bodyto energy consuming implantable components of the apparatus. The energytransfer device may comprise said energiser unit is adapted to transformenergy from the control signal, as it is transmitted to the signalreceiver, into electric energy. Where the operation device comprises amotor the wireless energy transfer device is adapted to directly powerthe motor with transferred energy.

[0054] The energy transferred by the wireless energy transfer devicepreferably comprises a signal, suitably a wave signal. The energytransferred by the wireless energy transfer device may comprise anelectric field or a magnetic field or a combination thereof. The signalmay be analog or digital or a combination thereof. The energy transferdevice may transfer the energy from the signal into a direct, pulsatingdirect or alternating current or a combination thereof.

[0055] Any of the above mentioned signals may comprise analog or digitalpulses. The analog or digital signal may comprise a magnetic field or anelectric field or a combination thereof. Where the signal is a wavesignal it may comprise an electromagnetic wave signal, a sound wavesignal or a carrier wave signal for a remote control signal or acombination thereof. Where a carrier signal is used it may be frequency,amplitude or frequency and amplitude modulated.

[0056] The apparatus of the invention may comprise an implantable sourceof energy for powering the operation device and/or for energizing otherenergy consuming components of the apparatus, wherein the energy fromthe source of energy is releasable from outside the patient's body.Furthermore, the apparatus may comprise an energy transmission devicefor wireless transmission of energy of a first form and an energytransforming device implantable in the patient for transforming theenergy of the first form into energy of a second form, to be supplied tothe source of energy and/or other implantable energy consuming parts ofthe apparatus. The energy transforming device may transform the wirelessenergy directly or indirectly into energy different than the wirelessenergy for operation of the restriction device. Typically, the energy ofthe second form is different than the energy of the first form. Thefunction of the energy transmission device may be different from that ofthe energy transforming device.

[0057] An implantable motor or pump for operating the adjustment devicemay be provided, wherein the energy transmission device may be adaptedto transmit wireless energy in the form of a magnetic field orelectromagnetic waves or field for direct power of the motor or pump, asthe wireless energy is being transmitted. Suitably, the energytransmission device transmits energy by at least one signal separatefrom the above mentioned control signal.

[0058] An implantable stabiliser for stabilising the energy of the firstor second form may be provided. Where the energy of the second formcomprises electric current, the stabiliser suitably comprises at leastone capacitor.

[0059] Generally, the source of energy comprises a battery, accumulator,capacitor or a combination thereof.

[0060] In accordance with an embodiment of the invention, the apparatuscomprises a control device adapted to produce wireless energy fordirectly powering the operation device and/or for energizing otherenergy consuming components of the apparatus.

[0061] Generally, the wireless energy may comprise a wave signalincluding a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal or a gammaradiation signal.

[0062] Any of the above mentioned signals may comprise a wave signalincluding a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal or a gammaradiation signal.

[0063] The control device may be adapted to produce wireless energy inthe form of a train of energy pulses and the energy transfer device maybe adapted to intermittently transfer the train of energy pulses fordirect use in connection with the energising of the energy consumingcomponents of the apparatus. Alternatively, the control device may beadapted to control the energy transforming device to produce the energyof the second form in said train of energy pulses for direct use inconnection with the operation of the adjustment device. The transferredenergy preferably comprises electric energy. An implantable capacitormay be provided for producing the train of energy pulses.

[0064] Where a capacitor is used in any of the above describedembodiments it may have a relatively low capacity, i.e. less than 0,1μF, in order to be small and suited for implantation.

[0065] Where the operation device comprises an implantable motor or pumpfor operating the adjustment device, the energy transfer device may beadapted to directly power the motor or pump with transferred energy, atthe same time as the energy is transferred. Where a pump is used itshould not be a plunger type of pump, because a plunger pump is noisy,but may comprise a peristaltic or membrane pump.

[0066] As mentioned above the apparatus comprises a wireless remotecontrol for non-invasively controlling the operation device, whichpreferably is electrically powered. Alternatively, the operation deviceis powered by magnetic energy, non-magnetic energy, electromagneticenergy, non-electromagnetic energy, kinetic energy, non-kinetic energy,sonic energy, non-sonic energy, thermal energy or non-thermal energy.However, the operation device may be unpowerable by permanent staticmagnetic energy. Any other kind of energy, such as electric,electromagnetic energy or a moving permanent magnetic energy, may beconceivable for operating the adjustment device. As a result, theimplanted restriction device would not be accidentally adjusted if thepatient comes close to any permanent magnet. Suitably, the operationdevice is adapted to non-invasively operate the adjustment device.

[0067] Where the operation device comprises a hydraulic operation deviceit may use hydraulic fluid, the viscosity of which changes when thehydraulic fluid is exposed to energy, preferably electric energy,different than thermal energy. However, use of hydraulic fluid of thekind having a viscosity that substantially increases when exposed toheat or a magnetic field, i.e. the hydraulic fluid would not become moreviscous when exposed to heat or influenced by magnetic forces, should beavoided, because external heat sources or heat from the body when thepatient has fever and external magnetic sources might affect theimplanted components of the apparatus.

[0068] The adjustment device is may be operable to adjust therestriction device to steplessly change the restriction of the bloodflow passageway. Furthermore, the adjustment device may be adapted tomechanically adjust the restriction device. Alternatively, it may beadapted to hydraulically adjust the restriction device by usinghydraulic means, which is devoid of hydraulic fluid of the kind having aviscosity that substantially increases when exposed to heat or amagnetic field.

[0069] In accordance with an embodiment of the invention, the apparatuscomprises a control device for controlling the restriction device. Thecontrol device may comprise an internal programmable control unitimplantable in the patient and, possibly an external control unitoutside the patient's body for programming the programmable internalcontrol unit. Alternatively, the external control unit may beprogrammable and wirelessly control the restriction device. The controldevice may be adapted to produce wireless energy for directly poweringthe operation device and/or for energizing other energy consumingcomponents of the apparatus.

[0070] At least one sensor for sensing at least one physical parameterof the patient may conveniently be implanted in the patient. The sensormay preferably sense as the physical parameter ejaculation, for exampleby sensing the pressure or flow in the patient's urethra, and either theinternal control unit or the external control unit of the control devicemay suitably control the restriction device to release the corporacavernosa or crura or the prolongations thereof in response to thesensor sensing ejaculation. For safety the restriction device mayrelease the corpora cavernosa or crura or the prolongations thereof inresponse to the sensor sensing for example an abnormally high pressurevalue. The internal control unit may directly control the restrictiondevice in response to signals from the sensor.

[0071] The pressure sensor may be any suitable known or conventionalpressure sensor such as shown in U.S. Pat. Nos. 5,540,731, 4,846,181,4738267, 4571749, 4407296 or 3939823; or an NPC-102 Medical AngioplastySensor.

[0072] Either the internal control unit or the external control unit ofthe control device may suitably control the restriction device toenlarge or close the blood flow passageway. For safety the restrictiondevice may enlarge or open the blood flow passageway in response to thesensor sensing for example an abnormally high pressure value. Theinternal control unit may directly control the restriction device inresponse to signals from the sensor.

[0073] Wherever magnetic means is utilized according to the invention itmay comprise a permanent magnet and a magnetic material reed switch, orother suitable known or conventional magnetic means.

[0074] Where a source of energy is used the control device suitably isoperable from outside the patient's body for controlling the source ofenergy to release energy for use in connection with the operation of theadjustment device, when the adjustment device is implanted. The sourceof energy may be provided external to the patient's body, and thecontrol device may be adapted to control the external source of energyto release wireless energy for use in connection with the operation ofthe adjustment device.

[0075] The control device may control the source of energy to releasemagnetic energy, non-magnetic energy, electromagnetic energy,non-electromagnetic energy, kinetic energy, non-kinetic energy, sonicenergy, non-sonic energy, thermal energy or non-thermal energy,preferably in a non-invasive manner and for a determined time periodand/or in a determined number of energy pulses.

[0076] Where the implantable components of the apparatus compriseelectrical components they may include at least one or a single voltagelevel guard. In this case, the electrical components suitably are devoidof any current detector and/or charge level detector. Furthermore, theelectrical components may comprise a capacitor or accumulator, whereinthe charge and discharge of the capacitor or accumulator is controlledby use of the voltage level guard. As a result, there is no need for anyimplanted current detector and/or charge level detector for the controlof the capacitor, which makes the apparatus simple and reliable.

[0077] In accordance with an advantageous embodiment of the invention,the apparatus comprises an implantable switch for directly or indirectlyswitching the operation of the restriction device. The switch may beoperated by the energy supplied by the energy transmission devicementioned above to switch from an off mode, in which the implantablesource of energy mentioned above is not in use, to an on mode, in whichthe source of energy supplies energy for the operation of therestriction device.

[0078] In accordance with an alternative embodiment, the above mentioneda remote control may be employed for controlling the implantable sourceof energy, wherein the switch is operated by the energy supplied by theenergy transmission device to switch from an off mode, in which theremote control is prevented from controlling the source of energy andthe source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the restriction device.

[0079] In accordance with another alternative embodiment, the switch isoperated by the energy supplied by the implantable energy transformingdevice mentioned above to switch from an off mode, in which the sourceof energy is not in use, to an on mode, in which the source of energysupplies energy for the operation of the restriction device.

[0080] In accordance with yet another alternative embodiment, the switchis operated by the energy supplied by the energy transforming device toswitch from an off mode, in which the remote control is prevented fromcontrolling the source of energy and the source of energy is not in use,to a standby mode, in which the remote control is permitted to controlthe source of energy to supply energy for the operation of therestriction device.

[0081] Suitably, the restriction device is embedded in a soft orgel-like material, such as a silicone material having hardness less than20 Shore.

[0082] The energy transforming device may be designed to be implantedsubcutaneously or in the abdomen, thorax or cephalic region of thepatient.

[0083] The adjustment device may be adapted to adjust the restrictiondevice such that the restriction device provides a predeterminedcontraction of the blood flow passageway that is satisfactory for thepatient.

[0084] All the above described various components, such as the motor,pump and capacitor, may be combined in the different embodiments whereapplicable. Also the various functions described in connection with theabove embodiments of the invention may be used in differentapplications, where applicable. Specifically, the various remote controlfunctions described and all the various methods for supplying energy maybe used in any conceivable combination that is apparent to those skilledin the art.

[0085] The invention also provides a method for treating male sexualimpotence, comprising surgically implanting in the body of a maleimpotent patient an adjustable restriction device engaging the corporacavernosa or crura or the prolongations thereof as a single unit, andwhen desired to achieve erection, adjusting the restriction device totemporarily contract the corpora cavernosa or crura or the prolongationsthereof to restrict the blood flow leaving the penis.

[0086] The invention also provides another method for treating malesexual impotence, comprising surgically implanting in the body of a maleimpotent patient at least two adjustable restriction devices engagingthe respective corpora cavernosa or crura or the prolongations thereofas separate units of the patients penis, and when desired to achieveerection, non-manually without touching the skin of the patientadjusting the restriction devices to temporarily contract the corporacavernosa or crura or the prolongations thereof to restrict the bloodflow leaving the penis. The method may further comprise surgicallyimplanting one or more non-manually adjustble powered restrictiondevices engaging respective exit veins from the penis.

[0087] The method may further comprise implanting a source of energy inthe patient and providing a control device for controlling the source ofenergy from outside the patient's body to supply energy to therestriction device or alternatively energising energy consumingcomponents of the apparatus with wirelessly transmitted energy fromoutside the patient's body.

[0088] The invention also provides a laparascopic surgical method. Thus,there is provided a method comprising the steps of placing at least twolaparascopical trocars in a male impotent patient's body, inserting adissecting tool through the trocars and dissecting an area of the penis,abdominal or pelvic or retroperitoneal surroundings, and placing anadjustable restriction device in the dissected area, so that therestriction device engages the corpora cavernosa or crura or theprolongations thereof.

[0089] The method may further comprise hydraulically adjusting therestriction device in a non-manual manner. The restriction device mayengage (a) both of the corpora cavernosa or crura or the prolongationsthereof as a single unit; or (b) one of the exit veins from the penis.

[0090] Alternatively, the method may further comprise implanting (a) afurther adjustable restriction device, wherein the two restrictiondevices engage the two corpora cavernosa or crura of the penis or theirprolongations, respectively, as separate units; or (b) severalrestriction devices engaging respective exit veins from the penis.

[0091] The method may further comprise implanting a source of energy inthe patient and providing a control device for controlling the source ofenergy from outside the patient's body to supply energy to therestriction device, and optionally also to other energy consumingcomponents of the apparatus, with wirelessly transmitted energy fromoutside the patient's body.

[0092] The operation device may preferably be powered with electricityand operated in a non-manual manner.

[0093] The invention is described in more detail in the following withreference to the accompanying drawings, in which

[0094] FIGS. 1A-D are block diagrams of four different principalembodiments of the male sexual impotence treatment apparatus accordingto the invention.

[0095]FIG. 2A-D are cross-sectional views of a pump mechanism accordingto FIG. 1C, which is designed to pump fluid in opposite directions bymechanically pushing a wall portion in only one direction.

[0096]FIG. 3 is a cross-sectional view of a reservoir having a variablevolume controlled by a remote control motor, in accordance with aparticular embodiment of the principal embodiment shown in FIG. 1B or2B.

[0097]FIG. 4 is a cross-sectional view of a reservoir having a variablevolume adjustable by manual manipulation, in accordance with aparticular embodiment of the principal embodiment shown in FIG. 1B or1D.

[0098]FIG. 5A is a perspective view of a hydraulic, pneumatic ormechanical servo system in accordance with a particular embodiment ofthe principal embodiment shown in FIG. 1D.

[0099]FIG. 5B is a cross-sectional view taken along line VB-VB of FIG.5A.

[0100]FIG. 6 is a block diagram illustrating remote control componentsof the device of the invention;

[0101]FIG. 7 is a schematic view of exemplary circuitry used for theblock diagram in FIG. 4;

[0102]FIG. 8 is a schematic view af a band with a cavity defining arestriction opening for use in accordance with the invention.

[0103]FIGS. 9A and 9B are schematic views of a first mechanicalrestriction device for use in accordance with the invention;

[0104]FIGS. 10A and 10B are schematic views of a second mechanicalrestriction device for use in accordance with the invention;

[0105]FIG. 11 is a schematic view of a third mechanical restrictiondevice for use in accordance with the invention;

[0106]FIG. 12A is a schematic front view of a fourth mechanicalrestriction device for use in accordance with the invention;

[0107]FIGS. 12B and 12C are sectional views along the line A-A of FIG.12A;

[0108]FIGS. 13A through 17B are five modifications of the embodiment ofFIGS. 12A-12C;

[0109]FIG. 18 is a view of an inflatable restriction device of theapparatus of the invention: and FIG. 19 illustrates the apparatus of theinvention implanted in a patient.

[0110] Referring to the drawing figures, like reference numeralsdesignate identical or corresponding elements throughout the severalfigures.

[0111] FIGS. 1A-D are a block diagrams of four different embodiments ofthe male sexual impotence treatment apparatus according to theinvention. FIG. 1A shows an elongated restriction member in the form ofa band 2 forming a loop which defines a restriction opening. The band 2provides a restricted blood through-flow area in the corpora cavernosawhen applied around the latter. FIG. 1A further shows a separatereservoir 4, a one way pump 6 and an alternate valve 8. FIG. 1B showsthe band 2 and a fluid supply reservoir 10. FIG. 1C shows the band 2, atwo-way pump 12 and the reservoir 4. FIG. 1D shows a servo system with afirst closed system controlling a second system. The servo systemcomprises the fluid supply reservoir 10 and a servo reservoir 14. Theservo reservoir 14 controls a larger adjustable reservoir 16 which inconnection with the band 2 applied around the corpora cavernosa variesthe volume of a cavity in the band, which in turn varies the restrictedblood through-flow area in the corpora cavernosa. Such a band 2 formingthe restriction opening 3 is illustrated schematically in FIG. 8. Theband 2 comprises an adjustment device having an expandable/contractabecavity 5 which is expanded or contracted by supplying hydraulic fluid(e.g. from reservoir 4, 6, 10, or 16), and the band 2 may be sutured inplace, illustrated schematically at 7 in FIG. 8.

[0112] FIGS. 2A-D are cross-sectional views of a pump mechanism adaptedto pump fluid in both directions only by mechanically pushing a separatesealing wall portion 18 in one direction. FIG. 2A shows a piston 20pushed forwards against a spring 22 towards the wall portion 18 andlocated in a pump housing 24 conducting fluid from a right upper fluidpassage 26 of the housing 24 to a left fluid passage 28 of the housing24. A main valve 30 is open and a non-return valve 32 is closed. FIG. 2Billustrates the first pump movement in which the piston 20 has movedforwards and reaches the wall portion 18. FIG. 2C illustrates how thepiston 20 moves backwards by the action of the spring 22. The main valve30 is now closed and the non-return valve 32 is open for fluid from theright upper passage 26. FIG. 1D illustrates how the piston 20 is movedfurther downwards from its position according to FIG. 2B while pushingthe wall portion 18 downwardly against a second spring 34 that isstronger than spring 22, whereby fluid escapes from a right lower fluidpassage 36. When moving the piston 20 backwardly from the positionaccording to FIG. 2D, fluid enters the left fluid passage 28 and a valve38 in the lower right fluid passage 36 closes.

[0113]FIG. 3 is a cross-sectional view of a reservoir 40 defining achamber 42, the volume of which is variable and is controlled by aremote controlled electric motor 44, in accordance with FIG. 1B or 1D.The reservoir 40 and the motor 44 are placed in a housing 46. Thechamber 42 is varied by moving a large wall 48. The wall 48 is securedto a nut 50, which is threaded on a spindle 52. The spindle 52 isrotated by the motor 44 via an angular gearing, which comprises twoconical gear wheels 54 and 56 in mesh with each other. The motor 44 ispowered by a battery 58 placed in the housing 46. An signal receiver 60for controlling the motor 44 is also placed in the housing 46.Alternatively, the battery 58 and the signal receiver 60 may be mountedin a separate place. The motor 44 may also be powered by energytransferred from transmitted signals.

[0114]FIG. 4 is a cross-sectional view of a reservoir 62 defining achamber 64, the volume of which is variable and is controlled by manualmanipulation. A gable wall portion 66 of an open ended inner cylindricalhousing 68 is adapted to be pushed downwards to fit in a desired lockinggroove 70 of a plurality of locking grooves 70 on the mantle wall of thecylindrical housing 68, to reduce the volume of the chamber 64. Theinner cylindrical housing 68 is suspended by springs 72 and istelescopically applied on an outer cylindrical housing 74. When pushingthe inner cylindrical housing 68 it moves downwards relative to theouter cylindrical housing 74 causing the gable wall portion 66 torelease from the locking groove 70 and move upwards relative to theinner cylindrical housing 68. When the inner housing 68 is movedupwardly by the action of the springs 72 the volume of the chamber 64 isincreased.

[0115]FIGS. 5A and 5B show a servo means comprising a main ring-shapedfluid reservoir 76 defining a chamber 78, the volume of which isvariable. Centrally positioned in the main ring-shaped reservoir 76there is a servo fluid reservoir 80 defining a chamber 82, the volume ofwhich is variable. The chamber 82 of the servo reservoir 80 issubstantially smaller than the chamber 78 of the main reservoir 76. Thetwo reservoirs 76 and 80 are situated between two opposite separatewalls 84 and 86, and are secured thereto. When changing the amount offluid in the servo reservoir 80, the two opposite walls 84,86 are movedtowards or away from each other, whereby the volume of the chamber 78 ofthe main reservoir 76 is changed.

[0116]FIG. 6 shows the basic parts of a remote control system of theapparatus of the invention including the electric motor 44 of theembodiment shown in FIG. 3. In this case, the remote control system isbased on the transmission of electromagnetic wave signals, often of highfrequencies in the order of 100 kHz-1 gHz, through the skin 130 of thepatient. In FIG. 6, all parts placed to the left of the skin 130 arelocated outside the patient's body and all parts placed to the right ofthe skin 130 are implanted. Any suitable remote control system may beused.

[0117] An external signal transmitting antenna 132 is to be positionedclose to a signal receiving antenna 134 implanted close to the skin 130.As an alternative, the receiving antenna 134 may be placed for exampleinside the abdomen of the patient. The receiving antenna 134 comprises acoil, approximately 1-100 mm, preferably 25 mm in diameter, wound with avery thin wire and tuned with a capacitor to a specific high frequency.A small coil is chosen if it is to be implanted under the skin of thepatient and a large coil is chosen if it is to be implanted in theabdomen of the patient. The transmitting antenna 132 comprises a coilhaving about the same size as the coil of the receiving antenna 134 butwound with a thick wire that can handle the larger currents that isnecessary. The coil of the transmitting antenna 132 is tuned to the samespecific high frequency as the coil of the receiving antenna 134.

[0118] An external control unit 136 comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas132,134 to an implanted control unit 138. To avoid that accidentalrandom high frequency fields trigger control commands, digital signalcodes are used. A conventional keypad placed on the external controlunit 136 is connected to the microprocessor thereof. The keypad is usedto order the microprocessor to send digital signals to either increaseor decrease the size of the restriction opening defined by the loop ofthe restriction member 2. The microprocessor starts a command byapplying a high frequency signal on the antenna 132. After a short time,when the signal has energized the implanted parts of the control system,commands are sent to increase or decrease the size of the restrictionopening of the restriction member 2 in predefined steps. The commandsare sent as digital packets in the form illustrated below. Startpattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

[0119] The commands are sent continuously during a rather long timeperiod (e.g. about 30 seconds or more). When a new increase or decreasestep is desired the Count byte is increased by one to allow theimplanted control unit 138 to decode and understand that another step isdemanded by the external control unit 136. If any part of the digitalpacket is erroneous, its content is simply ignored.

[0120] Through a line 140, an implanted energiser unit 126 draws energyfrom the high frequency electromagnetic wave signal received by thereceiving antenna 134. The energiser unit 126 stores the energy in apower supply, such as a large capacitor, powers the control unit 138 andpowers the electric motor 44 via a line 142.

[0121] The control unit 138 comprises a demodulator and amicroprocessor. The demodulator demodulates digital signals sent fromthe external control unit 136. The microprocessor of the control unit138 receives the digital packet, decodes it and, provided that the powersupply of the energiser unit 126 has sufficient energy stored, sends asignal via a signal line 144 to the motor 44 to either increase ordecrease the size of the restriction opening of the restriction member 2depending on the received command code.

[0122] Alternatively, the energy stored in the power supply of theenergiser unit may only be used for powering a switch, and the energyfor powering the motor 44 may be obtained from another implanted powersource of relatively high capacity, for example a battery. In this casethe switch is adapted to connect the battery to the control unit 138 inan on mode when the switch is powered by the power supply and to keepthe battery disconnected from the control unit in a standby mode whensaid switch is unpowered.

[0123] With reference to FIG. 7, the remote control system schematicallydescribed above will now be described in accordance with a more detailedembodiment. The external control unit 136 comprises a microprocessor146, a signal generator 148 and a power amplifier 150 connected thereto.The microprocessor 146 is adapted to switch the signal generator 148on/off and to modulate signals generated by the signal generator 148with digital commands that are sent to implanted components of therestriction device. The power amplifier 150 amplifies the signals andsends them to the external signal transmitting antenna 132. The antenna132 is connected in parallel with a capacitor 152 to form a resonantcircuit tuned to the frequency generated by the signal generator 148.

[0124] The implanted signal receiving antenna coil 134 forms togetherwith a capacitor 154 a resonant circuit that is tuned to the samefrequency as the transmitting antenna 132. The signal receiving antennacoil 134 induces a current from the received high frequencyelectromagnetic waves and a rectifying diode 160 rectifies the inducedcurrent, which charges a storage capacitor 158. A coil 156 connectedbetween the antenna coil 134 and the diode 160 prevents the capacitor158 and the diode 160 from loading the circuit of the signal receivingantenna 134 at higher frequencies. Thus, the coil 156 makes it possibleto charge the capacitor 158 and to transmit digital information usingamplitude modulation A capacitor 162 and a resistor 164 connected inparallel and a diode 166 forms a detector used to detect amplitudemodulated digital information. A filter circuit is formed by a resistor168 connected in series with a resistor 170 connected in series with acapacitor 172 connected in series with the resistor 168 via ground, anda capacitor 174, one terminal of which is connected between theresistors 168,170 and the other terminal of which is connected betweenthe diode 166 and the circuit formed by the capacitor 162 and resistor164. The filter circuit is used to filter out undesired low and highfrequencies. The detected and filtered signals are fed to an implantedmicroprocessor 176 that decodes the digital information and controls themotor 44 via an H-bridge 178 comprising transistors 180,182,184 and 186.The motor 44 can be driven in two opposite directions by the H-bridge178.

[0125] The microprocessor 176 also monitors the amount of stored energyin the storage capacitor 158. Before sending signals to activate themotor 44, the microprocessor 176 checks whether the energy stored in thestorage capacitor 158 is enough. If the stored energy is not enough toperform the requested operation, the microprocessor 176 waits for thereceived signals to charge the storage capacitor 158 before activatingthe motor 44.

[0126]FIGS. 9A and 9B show an embodiment of the apparatus of theinvention comprising a restriction device 202 having an elongatedflexible restriction member 204, such as a belt, a cord or the like. Theflexible member 204 extends in a loop around the corpora cavernosa.(Alternatively, the flexible member 204 may comprise two separate partson opposite sides of the corpora cavernosa.) One portion 204A of member204 is attached to a frame 208 and another portion 204B of member 204opposite portion 204A in the loop of the flexible member 204 isconnected to an adjustment device 210, which is fixed to the frame 208.The adjustment device 210 pulls the flexible member 204 away fromportion 204A to squeeze the corpora cavernosa between two oppositelengths of the flexible member 204 to thereby restrict the blood flowleaving the penis, see FIG. 9A, and releases the corpora cavernosa fromthe flexible member 204 to thereby increase the blood flow leaving thepenis, see FIG. 9B.

[0127]FIGS. 10A and 10B show an embodiment of the apparatus of theinvention comprising a restriction device 212 having two plate or barelements 214 on opposite sides of the corpora cavernosa 206. Anadjustment device 216 moves the elements 212 in parallel towards eachother to squeeze the corpora cavernosa 206 between the elements 212 tothereby restrict the blood flow leaving the penis, see FIG. 10A, andmoves the elements 212 away from each other to increase the blood flowleaving the penis, see FIG. 10B.

[0128]FIG. 11 shows an embodiment of the apparatus of the inventioncomprising a restriction device 218 having two articulated clampingelements 220 positioned on opposite sides of the corpora cavernosa 206.An adjustment device 222 moves the clamping elements 220 toward eachother to clamp the corpora cavernosa 206 between the clamping elements220 to thereby restrict the blood flow leaving the penis, and moves theclamping elements 220 away from each other to release the corporacavernosa 206 from the clamping elements 220 to thereby increase theblood flow leaving the penis.

[0129]FIGS. 12A, 12B and 12C show an embodiment of the apparatus of theinvention comprising a restriction device 224 having three bendingmembers in the form of cylindrical rollers 226, 228 and 230 displacedrelative one another in a row along the corpora cavernosa 206 andpositioned alternately on opposite sides of the corpora cavernosa 206.(Alternatively, each roller 226, 228 and 230 may take the shape of anhour-glass.) An adjustment device 232 moves the two outer rollers226,230 laterally against the corpora cavernosa 206 in one direction andthe intermediate roller 228 against the corpora cavernosa 206 in theopposite direction to bend the corpora cavernosa to thereby restrict theblood flow leaving the penis, see FIG. 12B. To release the corporacavernosa from the rollers 226-230, the adjustment device 232 moves therollers 226-230 away from the corpora cavernosa 206, see FIG. 12C.

[0130]FIGS. 13A through 17B schematically illustrates modifications ofthe above embodiment according to FIGS. 12A-12C. Thus, FIGS. 13A and 13Bshow an embodiment similar to that of FIGS. 12A-12C except that thebending members are oval and not rotatable. FIGS. 14A and 14B show anembodiment similar to that of FIGS. 13A and 13B except that the ovalbending members are rotatable to squeeze the corpora cavernosa, see FIG.14B, and to release the corpora cavernosa, see FIG. 14A. FIGS. 15A and15B show an embodiment similar to that of FIGS. 12A-12C except that theintermediate roller has a changeable diameter to squeeze the corporacavernosa, see FIG. 15B, and to release the corpora cavernosa, see FIG.15A. FIGS. 16A and 16B show an embodiment similar to that of FIGS.10A-10C except that the elements are replaced by two cylindrical rollerspositioned on opposite sides of the corpora cavernosa. Finally, FIGS.17A and 17B show an embodiment substantially similar to that of FIGS.16A and 16B except that the restriction device is turned 90 to form anS-shaped curvature of the corpora cavernosa.

[0131]FIG. 18 shows an example of a hydraulic restriction device 234 foruse in accordance with the invention. The restriction device 234comprises an elongated restriction member 236 having an inflatablecavity 238. A tube 240 connects the cavity 238 to a hydraulic fluidreservoir, not shown. The restriction member 236 may be wrapped aroundthe corpora cavernosa. Alternatively, two restriction members 236 may bewrapped around the respective crura.

[0132]FIG. 19 schematically illustrates how any of the above-describedembodiments of the male sexual impotence treatment apparatus of theinvention can be implanted in a patient. Thus, an implanted adjustablehydraulic restriction device 234 extends almost completely around thecorpora cavernosa 242 and the urethra 244 to be capable of contractingthe corpora cavernosa 242 as a single unit. An adjustment device in theform of an inflatable cavity in the restriction device 234 is adapted toadjust the restriction device 234 so that the blood flow leaving thepenis is restricted. An implanted assembly 246 includes a hydraulicfluid reservoir and a hydraulic operation device (which may include apump) for distributing hydraulic fluid between the reservoir and theinflatable/contractible cavity of the restriction device 234 via a fluidconduit 240.

[0133] A wireless remote control of the apparatus comprises an externalsignal transmitter 248, which may comprise a hand-held unit, and animplanted signal receiver, which is incorporated in the implantedassembly 246. The assembly 246 further includes a control unit forcontrolling the restriction device 234 in response to a control signalfrom the external transmitter. The signal receiver of the assembly 246further includes an energiser unit which transforms energy from thecontrol signal transmitted by the external transmitter into electricenergy for powering the operation device of the assembly 246 and forenergy consuming implanted components of the apparatus.

[0134] A pressure sensor 250 is implanted for sensing the pressure onthe restriction device 234. The control unit of the assembly 246controls the operation device of the assembly 246 to operate theadjustment device 234 to adjust the restriction device 234 so that thecorpora cavernosa is released in response to the pressure sensor 250sensing an abnormal high pressure.

[0135] There is a number of conceivable alternative embodiments of theinvention that give the same result as the above-described embodiments.For example, the microprocessor of the external and implanted,respectively, control units may be replaced by discrete components. Thepower amplifier of the external control unit may be omitted if thesignals generated by the signal generator are strong enough. Therefore,the invention is to be accorded the broadest interpretation of theappended claims to encompass all equivalent structures and assemblies.

1. A male sexual impotence treatment apparatus, comprising an adjustablerestriction device (2) implantable in a male patient, who suffers fromsexual impotence, for engaging the corpora cavernosa or crura or theprolongations thereof of the patient's penile tissue, an implantableadjustment device (5) for adjusting the restriction device totemporarily contract the corpora cavernosa or crura or the prolongationsthereof to restrict the blood flow leaving the penis, and an implantableoperation device (6,8;10;12;10,14;76-86) for operating the adjustmentdevice, characterised in that the operation device comprises a poweredoperation device.
 2. A male sexual impotence treatment apparatus,comprising an adjustable restriction device (2) implantable in a malepatient, who suffers from sexual impotence, for engaging the corporacavernosa or crura or the prolongations thereof of the patient's peniletissue, an implantable adjustment device (5) for adjusting therestriction device to temporarily contract the corpora cavernosa orcrura or the prolongations thereof to restrict the blood flow leavingthe penis, and an implantable operation device (6,8;10;12;10,14;76-86)for operating the adjustment device, characterised in that therestriction device is adapted to restrict the corpora cavernosa or cruraor the prolongations thereof as a single unit.
 3. An apparatus accordingto claim 1 or 2, further comprising a reservoir (4;10;16) implantable inthe patient and containing hydraulic fluid, wherein the operation device(6,8;10;12;10,14;76-86) is adapted to operate the adjustment device (5)by using the hydraulic fluid of the reservoir.
 4. An apparatus accordingto claim 3, Wherein the reservoir (4;10;16) contains a predeterminedamount of hydraulic fluid.
 5. An apparatus according to claim 3, whereinthe adjustment device comprises an expandable cavity (5) in therestriction device (2), the corpora cavernosa or crura or theprolongation thereof being contracted upon expansion of the cavity andreleased upon contraction of the cavity, and the hydraulic operationdevice (6,8;10;12;10,14;76-86) is adapted to distribute hydraulic fluidfrom the reservoir (4;10;16) to expand the cavity, and to distributehydraulic fluid from the cavity to the reservoir to contract the cavity.6. An apparatus according to claim 5, wherein the reservoir (10) definesa chamber (42;64) for said predetermined amount of fluid and theoperation device is adapted to change the size of the chamber.
 7. Anapparatus according to claim 6, wherein the operation device comprisesfirst and second wall portions (48;66) of the reservoir (10) and isadapted to provide relative displacement between the first and secondwall portions of the reservoir, in order to change the volume of thechamber (42;64).
 8. An apparatus according to claim 7, wherein theoperation device is adapted to provide said relative displacement inresponse to the pressure in the reservoir.
 9. An apparatus according toclaim 8, wherein the operation device comprises a pressure controlledhydraulic operation device.
 10. An apparatus according to claim 9,further comprising an alarm adapted to generate an alarm signal inresponse to the lapse of a predetermined time period during which thepressure controlling the hydraulic operation device exceeds apredetermined high value.
 11. An apparatus according to claim 7, whereinthe first and second wall portions of the reservoir (10) aredisplaceable relative to each other by magnetic means, hydraulic means,or electric control means, or a combination thereof.
 12. An apparatusaccording to claim 7, wherein the operation device is adapted todistribute fluid from the reservoir (10) to the cavity (5) of therestriction device (2) in response to a predetermined first displacementof the first wall portion (48;66) of the reservoir relative to thesecond wall portion of the reservoir and to distribute fluid from thecavity to the reservoir in response to a predetermined seconddisplacement of the first wall portion relative to the second wallportion.
 13. An apparatus according to claim 5, wherein the operationdevice comprises a pump (6,12) adapted to pump fluid between thereservoir (4) and the cavity (5) of the restriction device (2).
 14. Anapparatus according to claim 13, wherein the pump comprises a firstactivation member for activating the pump to pump fluid from thereservoir (4) to the cavity (5) of the restriction device (2) and asecond activation member for activating the pump to pump fluid from thecavity to the reservoir.
 15. An apparatus according to claim 14, whereinat least one of the activation members is adapted to operate whensubjected to a predetermined external pressure.
 16. An apparatusaccording to claim 14, wherein at least one of the first and secondactivating members are operable by magnetic means, hydraulic means,electric control means or manual manipulation means, or a combinationthereof.
 17. An apparatus according to any of claims 1-16, wherein theoperation device comprises a servo means.
 18. An apparatus according toany of claims 7, 11 or 13 wherein the operation device comprises areverse servo.
 19. A male sexual impotence treatment apparatus,comprising an adjustable restriction device (2) implantable in a malepatient, who suffers from sexual impotence, for engaging the corporacavernosa or crura or the prolongations thereof of the patient's peniletissue, an implantable adjustment device (5) for adjusting therestriction device to temporarily contract the corpora cavernosa orcrura or the prolongations thereof to restrict the blood flow leavingthe penis, and an implantable operation device (6,8;10;12;10,14;76-86)for operating the adjustment device, characterised in that the operationdevice comprises a servo means.
 20. An apparatus according to claim 19,wherein the operation device is powered.
 21. An apparatus according toclaim 19, wherein the operation device is manually operated.
 22. Anapparatus according to claim 19 or 20, wherein the servo means comprisesa motor, preferably an electric motor.
 23. An apparatus according toclaim 22, wherein the motor is reversible.
 24. An apparatus according toclaim 22 or 23, further comprising a gearing connected between the motorand the adjustment device.
 25. An apparatus according to any of claims19-21, further comprising an implantable reservoir (4;10;16) defining achamber for hydraulic fluid, wherein the operation device is adapted tooperate the adjustment device (5) by using the hydraulic fluid of thereservoir.
 26. An apparatus according to claim 25, Wherein the reservoir(4;10;16) contains a predetermined amount of hydraulic fluid.
 27. Anapparatus according to any of claims 19-21 or 25-26 wherein the servomeans comprises a reverse servo.
 28. An apparatus according to claims 25and 27, wherein the the reservoir (204) comprises first and second wallportions and the reverse servo is adapted to provide relativedisplacement between the first and second wall portions of thereservoir, in order to change the volume of the reservoir.
 29. Anapparatus according to claim 28 and, wherein the reverse servo device isadapted to provide said relative displacement in response to thepressure in the reservoir.
 30. An apparatus according to any of claims19-29, wherein the servo means comprises a pressure controlled servomeans.
 31. An apparatus according to claim 30, further comprising analarm adapted to generate an alarm signal in response to the lapse of apredetermined time period during which the pressure controlling theservo means exceeds a predetermined high value.
 32. An apparatusaccording to claim 27, wherein the reverse servo comprises magneticmeans, electric means or manual manipulation means or a combinationthereof.
 33. An apparatus according to claim 28, wherein the reverseservo comprises hydraulic means (10,14, 76-86).
 34. An apparatusaccording to claim 33, wherein the reverse servo further comprises aservo reservoir defining a chamber containing servo fluid, and theoperation device comprise first and second wall portions of the servoreservoir, which are displaceable relative to each other to change thevolume of the chamber of the servo reservoir.
 35. An apparatus accordingto claim 34, wherein the first and second wall portions of the servoreservoir are displaceable relative to each other by magnetic means,hydraulic means, or electric control means.
 36. An apparatus accordingto claim 33, wherein the reverse servo comprises a servo reservoir (14)and a fluid supply reservoir (10) connected in a closed system andcontaining a further predetermined amount of fluid.
 37. An apparatusaccording to claim 36, wherein the fluid supply reservoir (10) defines achamber for the further predetermined amount of fluid and the hydraulicoperation device is adapted to change the volume of the chamber andthereby control the amount of fluid in the servo reservoir (14).
 38. Anapparatus according to claim 37, wherein the fluid supply reservoir (10)comprises first and second wall portions, which are displaceablerelative to each other to change the volume of the chamber of the fluidsupply reservoir.
 39. An apparatus according to claim 38, wherein thefluid supply reservoir (10) increases the amount of fluid in the servoreservoir (14) in response to a predetermined first displacement of thefirst wall portion of the fluid supply reservoir relative to the secondwall portion of the fluid supply reservoir and decreases the amount offluid in the servo reservoir in response to a predetermined seconddisplacement of the first wall portion of the fluid supply reservoirrelative to the second wall portion of the fluid supply reservoir. 40.An apparatus according to any of claims 1 or 2 or 19, wherein theadjustment device comprises a hydraulic adjustment device, and furthercomprising a reservoir implantable in the patient and containing apredetermined amount of hydraulic fluid, and a conduit providing fluidconnection between the reservoir and the hydraulic adjustment device,the operation device being adapted to operate the hydraulic adjustmentdevice by distributing hydraulic fluid through the conduit between thereservoir and the hydraulic adjustment device, the conduit and hydraulicadjustment device being devoid of any non-return valve to permit freeflow of hydraulic fluid in both directions in the conduit.
 41. Anapparatus according to claim 40, wherein the reservoir forms a fluidchamber with a variable volume, and the operation device is adapted todistribute fluid from the chamber to the adjustment device by reductionof the volume of the chamber and to withdraw fluid from the adjustmentdevice by expansion of the volume of the chamber.
 42. An apparatusaccording to claim 41, wherein the operation device comprises a motor ora pump.
 43. An apparatus according to claim 41 or 42, wherein theoperation device comprises a movable wall of the reservoir for changingthe volume of the chamber.
 44. An apparatus according to claim 43,wherein the operation device is adapted to change the volume of thechamber by moving the movable wall in response to the pressure in thechamber.
 45. An apparatus according to claim 6 or 25, further comprisingan injection port subcutaneously implantable in the patient and in fluidcommunication with the chamber.
 46. An apparatus according to claim 45,wherein the injection port is integrated in the reservoir.
 47. Anapparatus according to claim 1 or 2 or 19, wherein the restrictiondevice comprises an elongated restriction member and forming means forforming the restriction member into at least a substantially closed looparound the corpora cavernosa or crura or the prolongations thereof, theloop defining a restriction opening, whereby the adjustment device isadapted to adjust the restriction member in the loop to change the sizeof the restriction opening.
 48. An apparatus according to claim 47,wherein the forming means forms the restriction member (2) into a loophaving a predetermined size or a size selected from severalpredetermined sizes.
 49. An apparatus according to claim 47, wherein theadjustment device is adapted to change the size of the restrictionopening such that the outer circumferential confinement surface of therestriction member is changed.
 50. An apparatus according to claim 47,wherein the adjustment device is adapted to change the size of therestriction opening such that the outer circumferential confinementsurface of the restriction member is unchanged.
 51. An apparatusaccording to claim 47, wherein the restriction member is non-inflatable,and the adjustment device is adapted to adjust the restriction member insaid loop.
 52. An apparatus according to claim 35, wherein theadjustment device mechanically adjusts the restriction member.
 53. Anapparatus according to claim 51, wherein the adjustment devicehydraulically adjusts the non-inflatable restriction member.
 54. Anapparatus according to claim 52 or 53, wherein the elongated restrictionmember (204) is flexible, and the adjustment device (210) is adapted topull a first portion (204A) of the flexible restriction member from asecond portion (204B) of the flexible restriction member opposite thefirst portion in the loop to squeeze the corpora cavernosa or crura orthe prolongations thereof between two opposite lengths of the elongatedflexible restriction member to restrict the blood flow leaving thepenis, and to release the corpora cavernosa or crura or theprolongations thereof from the flexible restriction member to restorethe blood flow.
 55. An apparatus according to claim 1 or 2 or 19,wherein the adjustment device mechanically adjusts the restrictiondevice.
 56. An apparatus according to any of claims 1 or 2 or 19 and 3or 40 or 55, wherein the restriction device (212) comprises at least twoelements (214) to be placed on different sides of the corpora cavernosaor crura or the prolongations thereof, and the adjustment device isadapted to squeeze the corpora cavernosa or crura or the prolongationsthereof between the elements to restrict the blood flow leaving thepenis, and to release the corpora cavernosa or crura or theprolongations thereof from the elements to restore the blood flow (FIGS.10A, 10B).
 57. An apparatus according to any of claims 1 or 2 or 19,wherein the restriction device (218) comprises at least two articulatedclamping elements (220) to be positioned on opposite or different sidesof the corpora cavernosa or crura or the prolongations thereof, and theadjustment device (222) is adapted to turn the clamping elements towardeach other to clamp the corpora cavernosa or crura or the prolongationsthereof between the clamping elements to restrict the blood flow leavingthe penis, and to turn the clamping elements away from each other torelease the corpora cavernosa or crura or the prolongations thereof fromthe elements to restore the blood flow (FIG. 11).
 58. An apparatusaccording to any of claims 1 or 2 or 19 and 3 or 40 or 55, wherein therestriction device is adapted to bend a portion of the corpora cavernosaor crura or the prolongations thereof (FIGS. 12A-17B).
 59. An apparatusaccording to claim 42, wherein the restriction device (224) comprises atleast two bending members (226-230) to be positioned on opposite sidesof the corpora cavernosa or crura or the prolongations thereof and to bedisplaced relative to each other along the corpora cavernosa or crura orthe prolongation thereof in the corpora cavernosa or crura or theprolongations thereof, and the adjustment device (232) is adapted tomove the bending members against the corpora cavernosa or crura or theprolongations thereof to bend them to restrict the blood flow leavingthe penis, and to move the bending members away from the corporacavernosa or crura or the prolongations thereof to release them from thebending members to restore the blood flow (FIGS. 12A-12C).
 60. Anapparatus according to claim 43, wherein the bending members compriserollers.
 61. An apparatus according to any of claims 1 or 19, whereinthe restriction device is adapted to rotate a portion of the corporacavernosa or crura or the prolongations thereof.
 62. An apparatusaccording to any of the preceding claims, further comprising a wirelessremote control (44,126,132-144) for non-invasively controlling thehydraulic operation device (6,8;10;12;10,14;76-86).
 63. An apparatusaccording to claim 62, wherein the remote control comprises an externalwireless hand-held remote control unit which is manually operable by thepatient to control the restriction device to squeeze or release thecorpora cavernosa or crura or the prolongations thereof.
 64. Anapparatus according to claim 62, wherein the remote control(44,126,132-144) comprises an external signal transmitter (132,136),receiver or transceiver and a signal receiver (134,138), transmitter ortransceiver implantable in the patient.
 65. An apparatus according toclaim 64, wherein the signal receiver (134,138) and/or transmittercomprises a control unit (138) adapted to control the operation device(6,8;10;12;10,14;76-86) in response to a control signal received fromthe signal transmitter (132, 136).
 66. An apparatus according to claim65, further comprising an implantable energizer unit (136) for providingenergy to energy consuming implantable components of the apparatus. 67.An apparatus according to claim 1 or 2 or 19 or 66, wherein theoperation device comprises a motor (44) for operating the adjustmentdevice.
 68. An apparatus according to claims 66 and 67, wherein thecontrol unit (138) is adapted to power the motor (44) with energyprovided by the energizer unit (136) in response to a control signalreceived from the signal transmitter (132,136).
 69. An apparatusaccording to claim 62, wherein the remote control (44,126,132-144)comprises wireless energy transfer means for transferring energy fromoutside the patient's body to energy consuming implantable components ofthe apparatus.
 70. An apparatus according to claim 66 and 69, whereinthe energy transfer means comprises an implantable energizer unit (126),which is adapted to transform energy from the control signal, as it istransmitted to the signal receiver (134,138), into electric energy. 71.An apparatus according to claim 69, wherein the operation device(6;8;10;12;10,14;76-86) comprises a motor (44), and the wireless energytransfer means is adapted to directly power the motor with transferredenergy.
 72. An apparatus according to claim 70 or 71, wherein the energytransferred by the wireless energy transfer means comprises a signal.73. An apparatus according to claim 72, wherein the signal comprises awave signal.
 74. An apparatus according to claim 70 or 71, wherein theenergy transferred by the wireless energy transfer means comprises anelectric field or a magnetic field or a combination thereof.
 75. Anapparatus according to claim 72, wherein the signal is analog or digitalor a combination thereof.
 76. An apparatus according to claim 64 or 65,wherein the signal transmitter (132,136) and signal receiver (134,138)are adapted to transmit and receive an analog or digital signal or acombination thereof.
 77. An apparatus according to claim 75 or 76,wherein the signal comprises analog or digital pulses.
 78. An apparatusaccording to any of claims 75-77, wherein the analog or digital signalcomprises a magnetic field or an electric field or a combinationthereof.
 79. An apparatus according to claim 64 or 65, wherein thesignal transmitter (132,136) and signal receiver (134,138) are adaptedto transmit and receive a wave signal.
 80. An apparatus according toclaim 72 or 79, wherein the wave signal comprises an electromagneticwave signal, a sound wave signal or a carrier wave signal for a remotecontrol signal or a combination thereof.
 81. An apparatus according toclaim 80, wherein the carrier signal is frequency, amplitude orfrequency and amplitude modulated.
 82. An apparatus according to claim72 or 75 wherein the energy transfer means transfers the energy from thesignal into a direct, pulsating direct or alternating current or acombination thereof.
 83. An apparatus according to claim 62, wherein theremote control (44,126,132-144) is capable of obtaining informationrelated to important parameters of the apparatus from iside thepatient's body and of commanding the adjustment device (5) to adjust therestriction device (2) in response to obtained information.
 84. Anapparatus according to claim 62, wherein the remote control is capableof obtaining information related to the contraction of the corporacavernosa or crura or the prolongations thereof and of commanding theadjustment device to adjust the restriction device in response toobtained information.
 85. An apparatus according to claim 1 or 2 or 19or 40 or 3 or 55, further comprising an implantable source of energy forpowering the operation device and/or for energizing other energyconsuming components of the apparatus, wherein the energy from thesource of energy is releasable from outside the patient's body.
 86. Anapparatus according to claim 1 or 2 or 19 or 40 or 3 or 55, furthercomprising an energy transmission device for wireless transmission ofenergy.
 87. An apparatus according to claim 85 and 86, wherein theenergy transmission device transmits energy of a first form, and furthercomprising an energy transforming device implantable in the patient fortransforming the energy of the first form into energy of a second form,to be supplied to the source of energy and/or other implantable energyconsuming parts of the apparatus.
 88. An apparatus according to claim87, wherein the energy of the second form is different than the energyof the first form.
 89. An apparatus according to claim 87, wherein theenergy transmission device functions different from the energytransforming device.
 90. An apparatus according to claim 86, furthercomprising an implantable motor or pump for operating the adjustmentdevice, wherein the energy transmission device is adapted to transmitwireless energy in the form of an magnetic field or electromagneticwaves or field for direct power of the motor or pump, as the wirelessenergy is being transmitted.
 91. An apparatus according to claim 65 and86, wherein the energy transmission device transmits energy by at leastone signal separate from the control signal.
 92. An apparatus accordingto claim 87, further comprising an implantable stabiliser forstabilising the energy of the first or second form.
 93. An apparatusaccording to claim 92, wherein the energy of the second form compriseselectric current and the stabiliser comprises at least one capacitor.94. An apparatus according to any of claims 85,87-89, wherein the sourceof energy comprises a battery, accumulator, capacitor or a combinationthereof.
 95. An apparatus according to claim 1 or 2 or 19 or 40 or 3 or55, further comprising a control device adapted to produce wirelessenergy for directly powering the operation device and/or for energizingother energy consuming components of the apparatus.
 96. An apparatusaccording to claim 1 or or 2 or 19 or 40 or 3 or 55, further comprisingan implantable energy transforming device for transforming wirelessenergy directly or indirectly into energy different than the wirelessenergy for operation of the restriction device.
 97. An apparatusaccording to claim 95 or 96, wherein the wireless energy comprises awave signal including a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal or a gammaradiation signal.
 98. An apparatus according to claim 1 or 2 or 19 or95, further comprising an energy transfer means (22,326,332-344) forwireless transfer of energy from outside the patient's body to theoperation device or adjustment device and/or other energy consumingimplantable components of the apparatus.
 99. An apparatus apparatusaccording to claim 95, wherein the control device is adapted to producewireless energy in the form of a train of energy pulses.
 100. Anapparatus according to claim 69 or 98, wherein the energy transfer meansis adapted to intermittently transfer the energy in the form of a trainof energy pulses for direct use in connection with the energising of theenergy consuming components of the apparatus.
 101. An apparatusaccording to claim 95 and 87 wherein the control device is adapted tocontrol the energy transforming device to produce the energy of thesecond form in a train of energy pulses for direct use in connectionwith the operation of the adjustment device.
 102. An apparatus accordingto claim 100 or 101, wherein the energy transfer device is adapted totransfer electric energy, and further comprising an implantablecapacitor for producing the train of energy pulses.
 103. An apparatusaccording to claim 102 or 93,94, wherein the capacitor has a capacityless than 0,1 μF.
 104. An apparatus according to claim 98, furthercomprising an implantable motor (22) or pump for operating theadjustment device (12;52;66;90,92;104;110), wherein the energy transfermeans is adapted to directly power the motor or pump with transferredenergy.
 105. An apparatus according to claim 90 or 104, wherein the pumpis not a plunger type of pump.
 106. An apparatus according to claim 1 or2 or 19 or 40 or 3 or 55, wherein the adjustment device is adapted toadjust the restriction device in a non-manual, non-thermal ornon-magnetic manner.
 107. An apparatus according to any of claims63-106, further comprising a wireless remote control (44,126,132-144)for non-invasively controlling the operation device(6,8;10;12;10,14;76-86).
 108. An apparatus according to any one of thepreceding claims, wherein the operation device is electrically powered.109. An apparatus according to claim 1 or 2 or 19 or 90, wherein theoperation device is unpowerable by static permanent magnetic energy.110. An apparatus according to claim 1 or 2 or 19 or 40 or 3 or 55,wherein the operation device is adapted to non-invasively operate theadjustment device.
 111. An apparatus according to claim 1 or 2 or 19 or40 or 3 or 55, wherein the adjustment device is operable to adjust therestriction device to steplessly change the contraction of the corporacavernosa or crura or the prolongation thereof.
 112. An apparatusaccording to claim 1 or 2 or 19 or 40 or 3, wherein the operation devicecomprises a hydraulic operation device which uses hydraulic fluid, theviscosity of which changes when the hydraulic fluid is exposed to energydifferent than thermal energy.
 113. An apparatus according to claim 108,wherein the viscosity of the hydraulic fluid changes when the fluid isexposed to electric energy.
 114. An apparatus according to claim 1 or 2or 19, further comprising an adjustment device for adjusting therestriction device to change the restriction of the faecal passageway,wherein the adjustment device is adapted to mechanically adjust therestriction device, or adapted to hydraulically adjust the restrictiondevice by using hydraulic means which is devoid of hydraulic fluid ofthe kind having a viscosity that substantially increases when exposed toheat or a magnetic field.
 115. An apparatus according to claim 1 or 2 or19, further comprising a control device for controlling the restrictiondevice.
 116. An apparatus according to claim 115, wherein the controldevice comprises an internal control unit implantable in the patient forcontrolling the restriction device.
 117. An apparatus according to claim116, wherein the internal control unit is programmable.
 118. Anapparatus according to claim 117, wherein the control device comprisesan external control unit outside the patient's body, the implantableinternal control unit being programmable by the external control unit.119. An apparatus according to claim 115, wherein the control devicecomprises an external control unit outside the patient's body forwirelessly controlling the restriction device.
 120. An apparatusaccording to claim 119, wherein the external control unit isprogrammable.
 121. An apparatus according to any one of the precedingclaims, further comprising at least one implantable sensor for sensingat least one physical parameter of the patient.
 122. An apparatusaccording to claim 121, wherein the sensor is adapted to directly orindirectly sense as the physical parameter the horisontal position ofthe patient.
 123. An apparatus according to claim 121, wherein thesensor comprises a pressure sensor for directly or indirectly sensing asthe physical parameter the pressure against the restriction device orpart of the human body.
 124. An apparatus according to claim 123,wherein the restriction device is adapted to enlarge the blood flowpassageway in the corpora cavernosa or crura or the prolongationsthereof in response to the pressure sensor sensing a predeterminedpressure.
 125. An apparatus according to any one of claims 121-124,further comprising a control device for controlling the restrictiondevice in response to signals from the sensor.
 126. An apparatusaccording to claim 125, wherein the control device comprises an internalcontrol unit implantable in the patient and directly controlling therestriction device in response to signals from the sensor.
 127. Anapparatus according to claim 126, wherein the control device comprisesan external control unit outside the patient's body for controlling therestriction device in response to signals from the sensor.
 128. Anapparatus according to claim 126, wherein the control device comprisesan external control unit outside the patient's body for manuallycontrolling the restriction device in response to information from thesensor.
 129. An apparatus according to claim 115, further comprising animplantable source of energy, wherein the control device is operablefrom outside the patient's body for controlling the source of energy torelease energy for use in connection with the operation of theprosthesis, when the prosthesis is implanted.
 130. An apparatusaccording to claim 129, wherein the source of energy is intended to beexternal to the patient's body, and the control device is adapted tocontrol the external source of energy to release wireless energy for usein connection with the operation of the prosthesis.
 131. An apparatusaccording to claim 129, wherein the control device controls the sourceof energy to release magnetic energy, non-magnetic energy,electromagnetic energy, non-electromagnetic energy, kinetic energy,non-kinetic energy, sonic energy, non-sonic energy, thermal energy ornon-thermal energy.
 132. An apparatus according to claim 1 or 2 or 19 or40 or 3 or 55, wherein the operation device is powered by magneticenergy, non-magnetic energy, electromagnetic energy, non-electromagneticenergy, kinetic energy, non-kinetic energy, sonic energy, non-sonicenergy, thermal energy or non-thermal energy.
 133. An apparatusaccording to claim 129, wherein the control device controls the sourceof energy to release energy for a determined time period.
 134. Anapparatus according to claim 129 or 129 and 99, wherein the controldevice controls the source of energy to release energy in a determinednumber of energy pulses.
 135. An apparatus according to claim 129,wherein the control device is adapted to control the source of energy torelease energy in a non-invasive manner.
 136. An apparatus according toclaim 1 or 2 or 19 or 40 or 3 or 55, further comprising implantableelectrical components including at least one voltage level guard. 137.An apparatus according to claim 1 or 2 or 19 or 40 or 3 or 55, furthercomprising implantable electrical components including a single voltagelevel guard.
 138. An apparatus according to claim 136 or 137, whereinthe electrical components are devoid of any current detector and/orcharge level detector.
 139. An apparatus according to any of claims 85,102, 87, 93 or 94 and 136-138, further comprising an implantablecapacitor or accumulator, wherein the charge or discharge of thecapacitor or accumulator is controlled by use of the voltage levelguard.
 140. An apparatus according to claim 65, 70 or 91, wherein thecontrol signal comprises a wave signal including a sound wave signal, anultrasound wave signal, an electromagnetic wave signal, an infraredlight signal, a visible light signal, an ultra violet light signal, alaser light signal, a micro wave signal, a radio wave signal, an x-rayradiation signal or a gamma radiation signal.
 141. An apparatusaccording to any of the preceding claims, further comprising a switchimplantable in the patient for directly or indirectly switching theoperation of the restriction device.
 142. An apparatus according toclaim 141 and 86, further comprising a source of energy implantable inthe patient for supplying energy for the operation of the restrictiondevice, wherein the switch is operated by the energy supplied by theenergy transmission device to switch from an off mode, in which thesource of energy is not in use, to an on mode, in which the source ofenergy supplies energy for the operation of the restriction device. 143.An apparatus according to claim 141 and 86, further comprising a sourceof energy implantable in the patient for supplying energy for theoperation of the restriction device, and a remote control forcontrolling the supply of energy of the implantable source of energy,wherein the switch is operated by the energy supplied by the energytransmission device to switch from an off mode, in which the remotecontrol is prevented from controlling the source of energy and thesource of energy is not in use, to a standby mode, in which the remotecontrol is permitted to control the source of energy to supply energyfor the operation of the restriction device.
 144. An apparatus accordingto claim 141 and 87, further comprising a source of energy implantablein the patient for supplying energy for the operation of the restrictiondevice, wherein the switch is operated by the energy supplied by theenergy transforming device to switch from an off mode, in which thesource of energy is not in use, to an on mode, in which the source ofenergy supplies energy for the operation of the restriction device. 145.An apparatus according to claim 141 and 87, further comprising a sourceof energy implantable in the patient for supplying energy for theoperation of the restriction device, and a remote control forcontrolling the supply of energy of the implantable source of energy,wherein the switch is operated by the energy supplied by the energytransforming device to switch from an off mode, in which the remotecontrol is prevented from controlling the source of energy and thesource of energy is not in use, to a standby mode, in which the remotecontrol is permitted to control the source of energy to supply energyfor the operation of the restriction device.
 146. An apparatus accordingto claim 1 or 2 or 19 or 40 or 3 or 55, wherein the prosthesis isoperable to perform a reversible function.
 147. An apparatus accordingto claim 67 or 146, further comprising a reversing device implantable inthe patient for reversing the function performed by the prosthesis. 148.An apparatus according to claim 147, wherein the control device controlsthe reversing device to reverse the function performed by theprosthesis.
 149. An apparatus according to claim 147, wherein thereversing device comprises hydraulic means including a valve forshifting the flow direction of a flowing fluid in the hydraulic means.150. An apparatus according to claim 147, wherein the reversing devicecomprises a mechanical reversing device.
 151. An apparatus according toclaim 147, wherein the reversing device comprises a switch.
 152. Anapparatus according to claim 151, wherein the switch of the reversingdevice is operable by the released energy.
 153. An apparatus accordingto claim 152, wherein the control device controls the operation of theswitch of the reversing device by shifting polarity of the releasedenergy supplied to the switch.
 154. An apparatus according to claim 147,wherein the operation device comprises a motor, and the reversing devicereverses the motor.
 155. An apparatus according to any of the precedingclaims, wherein the restriction device is embedded in a soft or gel-likematerial.
 156. An apparatus according to claim 155, wherein therestriction device is embedded in a silicone material having hardnessless than 20 Shore.
 157. An apparatus according to claim 87, wherein theenergy transforming means or device is designed to be implantedsubcutaneously or in the abdomen, thorax or cephalic region of thepatient.
 158. An apparatus according to claim 125, wherein therestriction device is adapted to release the corpora cavernosa or cruraor the prolongations thereof in response to the sensor sensingejaculation.
 159. An apparatus according to any of the preceding claims,wherein the restriction device is adapted to restrict the corporacavernosa or crura or the prolongations thereof as a single unit. 160.An apparatus according to any of the preceding claims, wherein therestriction device further comprises two restriction members adapted torestrict the respective corpora cavernosa or crura or the prolongationsthereof.
 161. An apparatus according to any of the preceding claims,wherein the restriction device further is adapted to restrict at leastone of the penile exit veins.
 162. An apparatus according to any of thepreceding claims, wherein the adjustment device is adapted to adjust therestriction device such that the restriction device provides apredetermined contraction of the corpora cavernosa or crura or theprolongations thereof that is satisfactory for the patient.
 163. Anapparatus according to claim 1 or 19, wherein the adjustment device isadapted to adjust the restriction device in a non-flux magnetic ornon-thermal manner or non-viscosity changing manner.